Quality Assurance Specialist
Commonwealth Sciences, Inc.
Greater Boston
See who Commonwealth Sciences, Inc. has hired for this role
Position located in Waltham, MA
Responsibilities of the Quality Assurance Specialist:
- May be required to assist with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
- Provide QA support of change controls, GMP investigations and CAPAs.
- Participate in compliance walkthroughs and help drive the closure of any audit observations.
- Generation, review and maintenance of Quality System documentation and procedures.
- Provision of suggestions and comments, evaluation and approval of changes directly related to the critical systems, manufacture and analytical methods.
- Review of standard operating procedures.
- Review of GMP related documents, such as specifications, methods, validation documents, technology transfer documents, etc.
Requirements of the Quality Assurance Specialist:
- BS degree in Biology, Chemistry, or related area.
- Must have 3+ years Quality Assurance in a GMP environment.
- Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Quality Assurance, Science, and Research -
Industries
Staffing and Recruiting
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